Diabetic peripheral neuropathy (DPN) represents a diffuse symmetric and length-dependent injury to peripheral nerves that has major implications on quality of life (QOL), morbidity, and costs from a public health perspective. Painful diabetic neuropathy affects approximately 16% of patients with diabetes. Pharmacological agents used in the management of painful DPN mainly include tricyclic antidepressants, selective serotonin and norepinephrine reuptake inhibitors, opioid, and anti epileptic drugs. The available treatment options do not give total relief, are not effective in all patients, and only about one-third of patients may achieve more than 50% pain relief. Hence newer therapies are required for the treatment of DPN. The primary outcome measures will be the change from baseline to end of treatment in the mean 24-hour average pain intensity.

Patients with diabetes mellitus with painful peripheral neuropathy for at least 6 months

A baseline 24-hour average daily pain intensity score ≥5

Women must be of non child-bearing potential, defined as post menopausal or surgically sterile

Exclusion Criteria:

Other chronic pain conditions not associated with DPN, that may confound the assessment of neuropathic pain

Other causes of neuropathy or lower extremity pain

Complex regional pain syndrome or trigeminal neuralgia

Lower extremity amputations other than toes

Participation in another study with an investigational compound within the previous 90 days prior to study medication administration, or concurrent participation in another clinical study

Major depression.

Presence or history of cancer within the past 5 years with the exception of adequately treated localized basal cell skin cancer or in situ uterine cervical cancer.

Patients with clinically significant or uncontrolled hepatic, gastrointestinal, cardiovascular, respiratory, neurological (other than neuropathy), psychiatric, hematological, renal, or dermatological disease, or any other medical condition that according to Investigator's medical judgment: Could interfere with the accurate assessment of safety or efficacy, or, Could potentially affect a patient's safety or study outcome

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01726413

Locations

Czech Republic

NeuroHelp s.r.o

Olomouc, Prague, Czech Republic, 772 00

DADO Medical s.r.o

Prague, Czech Republic, 12000

DADO Medical s.r.o

Ricany, Czech Republic

Germany

Institute for Clinical Research and Development( IKFE-CRO GmbH BahnhofstraBe 8A)

Mainz, Germany, 55116

India

Bangalore Clinisearch

Bangalore, Karnataka, India, 560043

K.L.E.S Dr. Prabhakar Kore Hospital & Medical research Centre

Belgaum, Karnataka, India, 590010

Jnana Sanjeevani Medical Centre

Bangalore, Karntaka, India, 560078

TOTALL Diabetes Hormone Institute

Indore, Madhya Pradesh, India, 452010

Jehangir Clinical development Centre Pvt Ltd

Pune, Maharashtra, India, 411001

Getwell Hospital and Research Centre

Nagpur, Maharastra, India, 440012

MV Hospital for Diabetes (P) Ltd

Chennai, Tamil Nadu, India, 600 013

Kovai Diabetes Speciality Centre and Hospital

Coimbatore, Tamil Nadu, India, 641 009

Arthur Asirvathma Hospital

Madhurai, Tamil Nadu, India, 625020

Maulana Azad Medical College & Associate Hospitals

New Delhi, India, 110002

United Kingdom

ICON Manchester CPU

Manchester, UK, United Kingdom, M15 6SH

Sponsors and Collaborators

Glenmark Pharmaceuticals Ltd. India

Glenmark Pharmaceuticals S.A.

Investigators

Principal Investigator:

Dr. Balamurugan Ramanathan

Kovai Diabetes Speciality Centre and Hospital

Principal Investigator:

Dr. Vijay Viswanathan

MV Hospital for Diabetes (P) Ltd

Principal Investigator:

Dr. Mallikarjun V Jali

K.L.E.S Dr. Prabhakar Kore Hospital & Medical research Centre

Principal Investigator:

Dr. Sunil M Jain

TOTALL Diabetes Hormone Institute

Principal Investigator:

Dr. Dinesh Dhanwal

Maulana Azad Medical College & Associate Hospitals

Principal Investigator:

Dr. S Srikanta

Jnana Sanjeevani Medical Centre

Principal Investigator:

Dr. Jayashri Shembalkar

Getwell Hospital and Research Centre

Principal Investigator:

Dr Peter Dewland

ICON Manchester CPU

Principal Investigator:

Dr. Prof Thomas Forst

Institute for Clinical Research and Development( IKFE-CRO GmbH BahnhofstraBe 8A)